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NCT01524783 · OUTCOME

Change From Baseline in Neuron Specific Enolase (NSE) Levels

Everolimus Plus Best Supportive Care vs Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Neuroendocrine Tumors (GI or Lung Origin) · Source last updated 2021-08-05

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEAN
Unit: microgram/liter (ug/L)
Interval / dispersion: Standard Deviation
Time frame: From baseline (every 4 weeks) up to Week 116

What was measured

NSE is a potential biomarker for tumor response. Blood samples were collected for assessment of NSE levels. Change from Baseline at a particular visit was calculated as the NSE level at that visit minus Baseline.

Analysis population: The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization. Number analyzed signified number of participants with available data for this outcome measure at specified timepoints.

Groups in this outcome

Everolimus + BSC

Participants received everolimus 10 mg once daily BSC throughout the study

Placebo + BSC

Participants received matching placebo once daily plus BSC during the blinded period. Participants were allowed to crossover to treatment with everolimus 10mg once daily plus BSC during the open-label period

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	205
Placebo + BSC	97

Reported measurements

Week 4

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	158
Placebo + BSC	89

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	0.1	5.21	Not reported	Not reported	Not reported
Placebo + BSC	-2.2	39.87	Not reported	Not reported	Not reported

Week 8

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	151
Placebo + BSC	85

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	0.3	8.71	Not reported	Not reported	Not reported
Placebo + BSC	-4.2	36.71	Not reported	Not reported	Not reported

Week 12

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	139
Placebo + BSC	74

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	-0.3	8.37	Not reported	Not reported	Not reported
Placebo + BSC	15.5	163.75	Not reported	Not reported	Not reported

Week 16

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	135
Placebo + BSC	62

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	2.0	8.34	Not reported	Not reported	Not reported
Placebo + BSC	4.1	19.44	Not reported	Not reported	Not reported

Week 20

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	128
Placebo + BSC	50

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	0.8	6.21	Not reported	Not reported	Not reported
Placebo + BSC	5.3	18.26	Not reported	Not reported	Not reported

Week 24

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	117
Placebo + BSC	39

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	1.7	8.99	Not reported	Not reported	Not reported
Placebo + BSC	6.7	23.47	Not reported	Not reported	Not reported

Week 28

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	110
Placebo + BSC	35

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	1.1	6.37	Not reported	Not reported	Not reported
Placebo + BSC	0.4	9.16	Not reported	Not reported	Not reported

Week 32

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	106
Placebo + BSC	31

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	1.5	14.24	Not reported	Not reported	Not reported
Placebo + BSC	3.1	8.96	Not reported	Not reported	Not reported

Week 36

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	96
Placebo + BSC	27

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	2.0	15.11	Not reported	Not reported	Not reported
Placebo + BSC	2.0	5.90	Not reported	Not reported	Not reported

Week 40

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	86
Placebo + BSC	24

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	1.2	6.48	Not reported	Not reported	Not reported
Placebo + BSC	1.2	4.49	Not reported	Not reported	Not reported

Week 44

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	87
Placebo + BSC	23

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	0.8	5.10	Not reported	Not reported	Not reported
Placebo + BSC	1.2	4.46	Not reported	Not reported	Not reported

Week 48

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	74
Placebo + BSC	23

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	2.0	9.20	Not reported	Not reported	Not reported
Placebo + BSC	0.6	4.06	Not reported	Not reported	Not reported

Week 52

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	71
Placebo + BSC	23

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	1.5	5.82	Not reported	Not reported	Not reported
Placebo + BSC	0.7	4.19	Not reported	Not reported	Not reported

Week 56

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	60
Placebo + BSC	21

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	3.6	18.56	Not reported	Not reported	Not reported
Placebo + BSC	0.9	5.89	Not reported	Not reported	Not reported

Week 60

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	63
Placebo + BSC	20

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	2.4	8.19	Not reported	Not reported	Not reported
Placebo + BSC	0.1	3.35	Not reported	Not reported	Not reported

Week 64

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	58
Placebo + BSC	18

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	4.4	23.22	Not reported	Not reported	Not reported
Placebo + BSC	0.9	3.80	Not reported	Not reported	Not reported

Week 68

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	58
Placebo + BSC	18

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	1.1	4.68	Not reported	Not reported	Not reported
Placebo + BSC	1.9	4.48	Not reported	Not reported	Not reported

Week 72

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	53
Placebo + BSC	18

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	1.6	4.46	Not reported	Not reported	Not reported
Placebo + BSC	0.7	3.91	Not reported	Not reported	Not reported

Week 76

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	52
Placebo + BSC	16

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	1.7	5.11	Not reported	Not reported	Not reported
Placebo + BSC	0.6	3.89	Not reported	Not reported	Not reported

Week 80

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	51
Placebo + BSC	13

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	2.9	10.15	Not reported	Not reported	Not reported
Placebo + BSC	0.7	2.83	Not reported	Not reported	Not reported

Week 84

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	41
Placebo + BSC	14

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	8.0	33.13	Not reported	Not reported	Not reported
Placebo + BSC	0.1	3.47	Not reported	Not reported	Not reported

Week 88

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	37
Placebo + BSC	11

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	2.2	3.89	Not reported	Not reported	Not reported
Placebo + BSC	0.6	2.47	Not reported	Not reported	Not reported

Week 92

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	29
Placebo + BSC	10

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	4.0	7.24	Not reported	Not reported	Not reported
Placebo + BSC	0.1	3.79	Not reported	Not reported	Not reported

Week 96

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	23
Placebo + BSC	10

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	4.3	5.96	Not reported	Not reported	Not reported
Placebo + BSC	0.0	2.99	Not reported	Not reported	Not reported

Week 100

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	22
Placebo + BSC	5

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	1.8	3.79	Not reported	Not reported	Not reported
Placebo + BSC	-0.2	5.10	Not reported	Not reported	Not reported

Week 104

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	15
Placebo + BSC	6

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	2.9	4.11	Not reported	Not reported	Not reported
Placebo + BSC	-1.7	4.76	Not reported	Not reported	Not reported

Week 108

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	12
Placebo + BSC	6

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	5.5	13.48	Not reported	Not reported	Not reported
Placebo + BSC	-0.5	4.33	Not reported	Not reported	Not reported

Week 112

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	11
Placebo + BSC	3

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	2.8	5.72	Not reported	Not reported	Not reported
Placebo + BSC	-3.2	3.30	Not reported	Not reported	Not reported

Week 116

Analysis denominator · Participants

Group	Source count
Everolimus + BSC	6
Placebo + BSC	4

Values in microgram/liter (ug/L) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + BSC	10.6	14.92	Not reported	Not reported	Not reported
Placebo + BSC	0.2	4.17	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
5.21
value
0.1
group Id
OG001
spread
39.87
value
-2.2
denoms
counts
group Id
OG000
value
158
group Id
OG001
value
89
units
Participants
title
Week 4
categories
measurements
group Id
OG000
spread
8.71
value
0.3
group Id
OG001
spread
36.71
value
-4.2
denoms
counts
group Id
OG000
value
151
group Id
OG001
value
85
units
Participants
title
Week 8
categories
measurements
group Id
OG000
spread
8.37
value
-0.3
group Id
OG001
spread
163.75
value
15.5
denoms
counts
group Id
OG000
value
139
group Id
OG001
value
74
units
Participants
title
Week 12
categories
measurements
group Id
OG000
spread
8.34
value
2.0
group Id
OG001
spread
19.44
value
4.1
denoms
counts
group Id
OG000
value
135
group Id
OG001
value
62
units
Participants
title
Week 16
categories
measurements
group Id
OG000
spread
6.21
value
0.8
group Id
OG001
spread
18.26
value
5.3
denoms
counts
group Id
OG000
value
128
group Id
OG001
value
50
units
Participants
title
Week 20
categories
measurements
group Id
OG000
spread
8.99
value
1.7
group Id
OG001
spread
23.47
value
6.7
denoms
counts
group Id
OG000
value
117
group Id
OG001
value
39
units
Participants
title
Week 24
categories
measurements
group Id
OG000
spread
6.37
value
1.1
group Id
OG001
spread
9.16
value
0.4
denoms
counts
group Id
OG000
value
110
group Id
OG001
value
35
units
Participants
title
Week 28
categories
measurements
group Id
OG000
spread
14.24
value
1.5
group Id
OG001
spread
8.96
value
3.1
denoms
counts
group Id
OG000
value
106
group Id
OG001
value
31
units
Participants
title
Week 32
categories
measurements
group Id
OG000
spread
15.11
value
2.0
group Id
OG001
spread
5.90
value
2.0
denoms
counts
group Id
OG000
value
96
group Id
OG001
value
27
units
Participants
title
Week 36
categories
measurements
group Id
OG000
spread
6.48
value
1.2
group Id
OG001
spread
4.49
value
1.2
denoms
counts
group Id
OG000
value
86
group Id
OG001
value
24
units
Participants
title
Week 40
categories
measurements
group Id
OG000
spread
5.10
value
0.8
group Id
OG001
spread
4.46
value
1.2
denoms
counts
group Id
OG000
value
87
group Id
OG001
value
23
units
Participants
title
Week 44
categories
measurements
group Id
OG000
spread
9.20
value
2.0
group Id
OG001
spread
4.06
value
0.6
denoms
counts
group Id
OG000
value
74
group Id
OG001
value
23
units
Participants
title
Week 48

denoms

counts
group Id
OG000
value
205
group Id
OG001
value
97
units
Participants

description

NSE is a potential biomarker for tumor response. Blood samples were collected for assessment of NSE levels. Change from Baseline at a particular visit was calculated as the NSE level at that visit minus Baseline.

dispersion Type

Standard Deviation

groups

description
Participants received everolimus 10 mg once daily BSC throughout the study
id
OG000
title
Everolimus + BSC
description
Participants received matching placebo once daily plus BSC during the blinded period. Participants were allowed to crossover to treatment with everolimus 10mg once daily plus BSC during the open-label period
id
OG001
title
Placebo + BSC

param Type

MEAN

population Description

The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization. Number analyzed signified number of participants with available data for this outcome measure at specified timepoints.

reporting Status

POSTED

time Frame

From baseline (every 4 weeks) up to Week 116

title

Change From Baseline in Neuron Specific Enolase (NSE) Levels

type

SECONDARY

unit Of Measure

microgram/liter (ug/L)

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice